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PreOperative Endocrine Therapy for Individualised Care With Abemaciclib (POETIC-A)
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery. Eligible patients will be randomised to standard adjuvant endocrine therapy alone or standard adjuvant endocrine therapy with a CDK4/6 inhibitor called abemaciclib.
Details
| Lead sponsor | Institute of Cancer Research, United Kingdom |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 123 |
| Start date | 2020-12-23 |
| Completion | 2030-10 |
Conditions
- Breast Cancer Female
Interventions
- Abemaciclib
- Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)
Primary outcomes
- Time to tumour (local or distant disease) recurrence — from randomisation until tumour recurrence or patient death, assessed up to 5 years
the time from randomisation to local, regional or distant tumour recurrence or death from breast cancer without prior notification of relapse. Second primary cancers and intercurrent deaths will be treated as censoring events.
Countries
United Kingdom